Download Quick guide to EMLA® anaesthetic times

Quick Guide-ny PI
0-03-30 13.01
Sidan 1
Quick guide to EMLA anaesthetic times
®
(lidocaine 2.5 % and prilocaine 2.5 %)
5–10 min
30– 60 min
procedure
dosage adults
SURGICAL REMOVAL OF MUCOSAL
GENITAL WARTS, BIOPSIES ON
MUCOSA
5–10 g no occlusion needed,
procedure immediately after removal of cream
DEBRIDEMENT OF LEG ULCERS
1–2 g/10 cm2 cream under occlusive dressing,
procedure immediately after removal of cream
1 g/10 cm2 cream under
occlusive dressing or one patch
SURGICAL TREATMENT OF
MOLLUSCUM CONTAGIOSUM
60 min
SURGICAL TREATMENT OF
SUPERFICIAL LESIONS
2 g/10 cm2 cream under occlusive dressing or
one patch
LASER TREATMENT OF PORT
WINE STAINS
COSMETIC PROCEDURES e.g.
Epilation and dermabrasion
NEEDLE INSERTIONS e.g.
Lumbar puncture
Haemodialysis
Prior to regional block
120 min
HARVESTING OF SPLIT-SKIN GRAFTS
dosage children*
1.5–2 g/10 cm2 cream under occlusive dressing
Before prescribing EMLA®, please refer to local product information.
*maximum dosage: Neonates 0-2 months 1 g, max 1 h.
Infants 3-11 months 2 g. Children 1- 5 years 10 g. Children 5-11 years 20 g.
1 g/10 cm2 cream under
occlusive dressing or one patch
Quick Guide-ny PI
0-03-30 13.01
Sidan 2
Abbreviated Prescribing Information:
See local Prescribing Information for full details, as Prescribing Information may vary from country
to country.
INDICATIONS
EMLA® Cream/Patch:Topical anaesthesia of the skin in connection with needle insertion, e.g. i.v.
catheters or blood sampling and superficial surgical procedures.
EMLA® Cream: Topical anaesthesia of the genital mucosa, e.g. prior to superficial surgical procedures or infiltration anaesthesia, and leg ulcers to facilitate mechanical cleansing/debridement.
DOSAGE AND ADMINISTRATION
Intact skin: EMLA Cream; apply a thick layer of cream to the skin 1.5–2 g/10 cm2 under an
occlusive dressing or EMLA Patch for 1 hour, maximum 5 hours.
Adults
Minor procedures, e.g. needle insertion and surgical treatment of localised lesions; Apply 2 g/10
cm2 (half a 5g tube) for a minimum of 1 hour, maximum 5 hours to a selected skin area. Dermal
procedures on larger areas, e.g split-skin grafting; Apply 1.5–2 g/10 cm2 under an occlusive dressing for a minimum of 2 hours, maximum 5 hours.
Children
Minor procedures, e.g. needle insertion and surgical treatment of localised lesions; Apply 1 g/10
cm2 of EMLA Cream under an occlusive dressing or EMLA anaesthetic patch for 1 hour.
Genital mucosa adults
Surgical treatment of localised lesions, e.g. removal of genital warts and prior to injection of local
anesthetics;Apply 5–10 g EMLA for 5–10 minutes, no occlusive dressing is required. Treatment
should start immediately after the removal of the cream.
LEG ULCERS ADULTS
Mechanical cleansing /debridement of leg ulcers; Apply a thick layer of EMLA Cream, approx. 1–2
g/10 cm2 up to a total of 10 g to the leg ulcer. Cover with an occlusive dressing. Apply for at least
30 minutes, up to 60 minutes may improve the anaesthesia further. Debridement should start
immediately after removal of the cream.
CONTRA-INDICATIONS
Hypersensitivity to local anaesthetics of the amide type or to any other component of the product.
Congenital or idiopathic methaemoglobinaemia.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Due to insufficient data on absorption, EMLA should not be applied to open wounds other than leg
ulcers. EMLA should not be used in infants between 0 and 12 months of age receiving treatment
with methaemoglobin-inducing agents or in preterm infants with a gestational age less than 37
weeks. Studies have been unable to demonstrate the efficacy of EMLA for heel lancing in neonates.
When applying EMLA to patients with atopic dermatitis a shorter application time, 15–30 minutes,
may be sufficient. EMLA should not be applied to the genital mucosa of children. When applied in
the vicinity of the eyes, EMLA Cream should be used with particular care since it causes corneal
irritation. EMLA should not be applied to an impaired tympanic membrane. The results of intracutaneous injections of live vaccines e.g. BCG should be monitored. In children/neonates younger
than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly
observed up to 12 hours after an application of EMLA.
PREGNANCY AND LACTATION
Lidocaine and prilocaine cross the placental barrier and may be absorbed by the fetal tissues. No
specific disturbances to the reproductive process have so far been reported. Lidocaine and, in all
probability, prilocaine are excreted in breast milk, but in such small quantities that there is generally no risk of the child being affected at therapeutic dose levels.
INTERACTIONS
With large doses of EMLA, consideration should be given to the risk of additional systemic toxicity
in patients receiving other local anaesthetics or agents structurally related to local anaesthetics,
since the toxic effects are additive.
UNDESIRABLE EFFECTS
Transient local reactions at the application site such as paleness, erythema. Skin sensations (an
initial mild burning or itching sensation at the application site).
Rare: Methaemoglobinaemia in children, discrete local lesions at the application
site (purpuric or petechial). In rare cases, local anaesthetic preparations
have been associated with allergic reactions.
(lidocaine 2.5 % and prilocaine 2.5 %)